(126 days)
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel
The system is intended for use by healthcare professionals.
The Interson USB Ultrasound Imaging System is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.
The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.
The Interson USB Ultrasound transducers operate in B-Mode, color Doppler, and combined mode (B + color Doppler), providing high resolution and high penetration performance. The product family uses curved and flat linear array transducers and includes a General Purpose (GP) probe and a Small Parts (SP) probe.
The SeeMore software application used in the Interson USB Ultrasound System supports static image acquisition and a cine function capable of storing up to 32 to 1024 sequential images. Management of patient history is enabled by the image or cine-storage function.
The SeeMore control software runs on standard Microsoft Windows platforms.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Interson USB Ultrasound System:
Summary of Acceptance Criteria and Device Performance:
Based on the provided document (K163443), the "acceptance criteria" are primarily established implicitly through compliance with recognized medical device standards and demonstrating substantial equivalence to predicate devices. There are no explicit quantitative performance metrics or threshold values listed as acceptance criteria in the manner typically seen for AI/ML device performance.
The device's performance is demonstrated through its successful compliance with these standards and the assertion that it introduces no new modes, features, or technologies requiring clinical testing beyond what is already "well-accepted" for predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by compliance/assertion) |
|---|---|
| Safety and Essential Performance (Electrical Safety) | Complies with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 for general requirements, and IEC 60601-2-37 (2015), Amendment 2 for specific requirements of ultrasonic medical diagnostic equipment. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.0 2014-02 for electromagnetic disturbances. |
| Acoustic Output | Complies with NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. |
| Usability | Complies with IEC 60601-1-6 Edition 3.1 2013-10 for usability. |
| Risk Management | Complies with ISO 14971 Second edition 2007-03-01 for application of risk management to medical devices. |
| Biocompatibility (Irritation and Skin Sensitization) | Complies with AAMI ANSI ISO 10993-10:2010/(R)2014 for tests for irritation and skin sensitization. |
| Biocompatibility (In Vitro Cytotoxicity) | Complies with AAMI ANSI ISO 10993-5:2009/(R)2014 for tests for in vitro cytotoxicity. |
| Equivalence of Intended Use/Indications for Use | The device's intended use and indications for use are substantially equivalent to predicate devices (Philips Lumify K152899 and Interson K070907), covering diagnostic ultrasound imaging in B, color Doppler, or Combined modes for specified applications (Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuro-muscular, Peripheral Vessel). |
| Equivalence of Technological Characteristics | The device is comparable to predicate devices in areas such as modes of operation (B, color Doppler, combined), array geometry (curved and linear), mechanics (solid-state), software platform (commercial off-the-shelf OS), software control (standalone), and measurement functions (2D and area). The differences (e.g., lack of wireless networking, USB connector type) are deemed not to raise new questions of safety or effectiveness. |
| Clinical Safety and Effectiveness (Implicit Equivalence) | "The Interson USB Ultrasound System product family introduces no new modes, features, or technologies relative to the predicate devices... that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices." This implies that by being substantially equivalent to devices whose safety and effectiveness are established, the subject device also meets these criteria without requiring new clinical trials. |
Detailed Information about the Study:
The document describes a premarket notification (510(k)) submission for substantial equivalence, not a clinical study involving specific performance metrics for image interpretation or AI assistance. Therefore, many of the requested details about a "study" in the context of AI device evaluation are not applicable to this submission.
-
Sample size used for the test set and the data provenance:
- N/A. This submission does not describe a clinical performance study with a test set of images or patient data to evaluate the device's diagnostic accuracy or performance against ground truth. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. As no clinical performance study with a test set was conducted for diagnostic accuracy, there were no experts used to establish ground truth in that context. The "ground truth" for this submission refers to compliance with established engineering and safety standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set or expert adjudication process for diagnostic performance was described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an ultrasound imaging system, not an AI-powered diagnostic assistance tool. Therefore, no MRMC study comparing human readers with or without AI assistance was conducted or is applicable. This submission predates widespread AI-driven medical imaging devices.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware/software system for ultrasound imaging, not a standalone AI algorithm. Its "performance" in the context of this submission is its ability to meet technical specifications and safety standards, and its equivalence to predicate devices, not its ability to make diagnostic interpretations without human involvement.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance and safety testing, the "ground truth" is defined by the specifications and acceptable limits set forth in the referenced recognized standards (e.g., NEMA UD 2-2004, IEC 60601 series, ISO 14971, ISO 10993 series). The device was tested to ensure it met these technical parameters.
-
The sample size for the training set:
- N/A. This device does not employ machine learning that would require a "training set" of data for an AI algorithm.
-
How the ground truth for the training set was established:
- N/A. No training set for an AI algorithm was used.
In conclusion, the K163443 submission details a regulatory pathway demonstrating substantial equivalence for a traditional medical imaging device (ultrasound system) by showing compliance with recognized safety and performance standards and by comparing its technological characteristics and indications for use to already legally marketed predicate devices. It does not involve the type of clinical performance study or AI/ML evaluation detailed in the questions.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2017
Interson Corporation % David Asarnow, Ph.D. Quality/Regulatory Manager 7150 Koll Center Parkway PLEASANTON CA 94566
Re: K163443
Trade/Device Name: Interson USB Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 17, 2017 Received: March 17, 2017
Dear Dr. Asarnow:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K163443
Device Name Interson USB Ultrasound System
Indications for Use (Describe)
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel
The system is intended for use by healthcare professionals.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
SECTION 1.3 - INDICATIONS FOR USE
The Interson USB Ultrasound System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal (conventional) Musculo-skeletal (superficial) Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel
The system is intended for use by healthcare professionals.
The Indications for Use statement on Form 3881 is provided in Tab 4, followed by the clinical applications and modes of operation applicable to each application for each transducer and for the system.
{4}------------------------------------------------
Diagnostic Ultrasound Indications for Use
Interson USB Ultrasound System
Device Name: GP-C01 Transducer
Mode: B, color Doppler, B + color Doppler
Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | N | N | N | |||||
| Abdominal | N | N | N | |||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | ||||||||
| Small Organ (Scrotum, prostate,lymph nodes, thyroid, breast) | N | N | N | |||||
| FetalImaging& Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | N | N | N | |||||
| Muscular-Skeletal (Superficial) | N | N | N | |||||
| Intravascular | ||||||||
| Other (Urology) | N | N | N | |||||
| Other (Gynecology) | N | N | N | |||||
| Other (Pelvic Floor) | N | N | N | |||||
| Other (Neuromuscular) | N | N | N | |||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = New Indication, P=Previously cleared by FDA; E=added under this appendix
*Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use
Interson USB Ultrasound System
Device Name: SP-L01 Transducer
Modes: B, color Doppler, B + color Doppler
Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | ||||||||
| Abdominal | N | N | N | |||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | N | N | N | |||||
| Small Organ (Scrotum, prostate,lymph nodes, thyroid, breast) | N | N | N | |||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| FetalImaging& Other | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | N | N | N | |||||
| Muscular-Skeletal (Superficial) | N | N | N | |||||
| Intravascular | ||||||||
| Other (Urology) | N | N | N | |||||
| Other (Gynecology) | N | N | N | |||||
| Other (Pelvic Floor) | N | N | N | |||||
| Other (Neuromuscular) | N | N | N | |||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | ||||
| Other (Specify) |
N = New Indication, P=Previously cleared by FDA; E=added under this appendix
*Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use
Device Name: Interson USB Ultrasound System
Modes: B, color Doppler, B + color Doppler
Intended Use: Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks 1&3) | B | M | PWD | CWD | ColorDoppler(CD) | Combined(B+CD) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal/Obstetric | N | N | N | |||||
| Abdominal | N | N | N | |||||
| Intra-Operative (Specify) | ||||||||
| Intra-Operative Neurological | ||||||||
| Laparoscopic | ||||||||
| Pediatric(excluding transcranial& neonatal) | N | N | N | |||||
| Small Organ (Scrotum, prostate,lymph nodes, thyroid, breast) | N | N | N | |||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Fetal | Trans-rectal | |||||||
| Imaging& Other | Trans-vaginal | |||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-card.) | ||||||||
| Muscular-Skeletal (Conventional) | N | N | N | |||||
| Muscular-Skeletal (Superficial) | N | N | N | |||||
| Intravascular | ||||||||
| Other (Urology) | N | N | N | |||||
| Other (Gynecology) | N | N | N | |||||
| Other (Pelvic Floor) | N | N | N | |||||
| Other (Neuromuscular) | N | N | N | |||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | ||||
| Other (Specify) |
N = New Indication, P=Previously cleared by FDA; E=added under this appendix
*Examples of other modes may include Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler and Color Velocity Imaging
{7}------------------------------------------------
510(k) Summary K163443
Provided in accordance with 21CFR 807.92 (c).
Submitter Information- 21 CFR 807.92 (a)(1)
| Date of submission: | 11/28/2016 |
|---|---|
| Submitter information: | Interson Corporation7150 Koll Center ParkwayPleasanton, CA 94566 |
| Establishment Registration No: | 2939830 |
| Contact person: | David AsarnowQuality/Regulatory Manager(925) 462-4948 (tel)(925) 462-4833 (fax)dasarnow@interson.com |
Name of Device and Classification - 21 CFR 807.92 (a)(2)
| Device trade name: | USB Ultrasound System |
|---|---|
| Common name: | Diagnostic ultrasound system and transducers |
| Classification: | Class II |
| 21 CFR Section | Classification Name | Product Code |
|---|---|---|
| 892.1550 | Ultrasonic pulsed doppler imaging system | IYN |
| 892.1560 | Ultrasonic pulsed echo imaging system | IYO |
| 892.1570 | Diagnostic ultrasonic transducer | ITX |
Track
Track 3
Predicate Device - 21 CFR 807.92 (a)(3)
| Philips Lumify Diagnostic Ultrasound System | K152899 | 10/30/2015 |
|---|---|---|
| Interson USB Ultrasound Probe System | K070907 | 4/17/2007 |
Device Description - 21 CFR 807.92 (a)(4):
The Interson USB Ultrasound Imaging System is a self-contained portable, solid-state, multiple-mode and multiple-application ultrasound imaging system. The system comprises a series of handheld probes containing an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, and
{8}------------------------------------------------
software-based controls offering a full complement of conventional operating modes, parameter controls, and recording functions. The selection of transducers offered with the system permit a wide range of clinical applications including Fetal/Obstetric, Abdominal, Pediatric, Small Organ, Musculo-skeletal, Urology, Gynecology, Pelvic Floor, Neuromuscular, and Peripheral Vessel.
The initial operational settings for each transducer are preprogrammed in the system. User-customized parameter settings for each transducer may be set by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the Cine function.
The Interson USB Ultrasound transducers operate in B-Mode, color Doppler, and combined mode (B + color Doppler), providing high resolution and high penetration performance. The product family uses curved and flat linear array transducers and includes a General Purpose (GP) probe and a Small Parts (SP) probe.
The SeeMore software application used in the Interson USB Ultrasound System supports static image acquisition and a cine function capable of storing up to 32 to 1024 sequential images. Management of patient history is enabled by the image or cine-storage function.
The SeeMore control software runs on standard Microsoft Windows platforms.
Intended Use/Indications for Use - 21 CFR 807.92 (a)(5)
The Interson Ultrasound Imaging System is intended for diagnostic ultrasound imaging in B, color Doppler, or Combined (B + Color) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications:
- Fetal/Obstetric Abdominal Pediatric Small Organ Musculo-skeletal Urology Gynecology Pelvic Floor Neuro-muscular Peripheral Vessel
The system is intended for use by healthcare professionals.
{9}------------------------------------------------
Product Models
| Model | Common Applications |
|---|---|
| Transducer Model GP-C01 | Fetal/Obstetric, Abdominal, Urology, Musculo-skeletal, Small Organs, Neuromuscular |
| Transducer Model SP-L01 | Pediatric, Small Organs, Peripheral Vessel |
All models are used with SeeMore control software.
Summary of technological characteristics of the device compared to the predicate device- 21 CFR 807.92 (a)(6)
| DeviceFeatures | Subject Device:Interson UltrasoundSystem | Predicate 1:Philips LumifyK152899 | Predicate 2:Interson UltrasoundSystem K070907 |
|---|---|---|---|
| Intended Use | Diagnostic ultrasoundimaging in B, colorDoppler andCombined (B + Color)modes. | Diagnostic ultrasoundimaging in B, colorDoppler, andCombined (B + Color)modes. | Diagnostic ultrasoundimaging in B mode(all transducers), Amode (ophthalmic) |
| Indicationsfor Use | Indicated fordiagnostic ultrasoundimaging and fluidflow analysis inspecified applications | Indicated fordiagnostic ultrasoundimaging and fluidflow analysis inspecified applications | Indicated fordiagnostic ultrasoundimaging in specifiedapplications |
| ArrayGeometry | Curved and linear | Curved and linear | Non-Array |
| Mechanics | Solid State | Solid State | Mechanical |
| Softwareplatform | Commercial off-the-shelf operating system(Windows) | Commercial off-the-shelf operating system(Android) | Commercial off-the-shelf operating system(Windows) |
| Softwarecontrol | Standalone | Standalone | Standalone |
| Measurementfunction | 2D measurement andarea measurement | 2D measurement tool | 2D measurement tool |
| Wirelessnetworking | Not supported | Supported | Not supported |
| Connector | USB | USB | USB |
{10}------------------------------------------------
Determination of Substantial Equivalence
Non-clinical Performance Data
Non-clinical testing relied on in this premarket notification submission for a determination of substantial equivalence include tests which show compliance with the following standards:
-
Recognition Number 12-105: NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. (Radiology)
-
Recognition Number 19-4: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
Recognition Number 12-293: IEC 60601-2-37 (2015), Amendment 2, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology) 4. Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
Recognition Number 5-89: IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
-
Recognition Number 5-40: ISO 14971 Second edition 2007-03-01, Medical devices -Application of risk management to medical devices 7. Recognition Number 2-173: AAMI ANSI ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
-
Recognition Number 2-153: AAMI ANSI ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Summary of Clinical Tests
The Interson USB Ultrasound System product family introduces no new modes, features, or technologies relative to the predicate devices (Philips Lumify K152899 and Interson K070907) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
514 Performance Standards
There are no Sec. 514 performance standards for this device.
{11}------------------------------------------------
Prescription Status
This is a prescription device. The prescription device statement appears in the labeling.
Sterilization Site(s) Not applicable. No components are supplied sterile.
Conclusions
Interson Corporation concludes that the subject device, the Interson Ultrasound USB Imaging System, has been shown to be substantially equivalent to the predicate devices identified above.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.